Glenmark Pharmaceuticals Gets ANDA Approval for Chlorpromazine Hydrochloride Tablets
Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine ®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline.
Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.
According to IQVIATM sales data for the 12 month period ending January 2021, the Thorazine ®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market2 achieved annual sales of approximately $108.6 million*.
Glenmark’s current portfolio consists of 171 products authorized for distribution in the U.S. marketplace and 41 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
